BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSPINE MC DRILL BASED GUIDE L05

    MDR report key: 9443539 · Received December 10, 2019

    Report

    Report Number
    3005180920-2019-01034
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630040717557
    PMA / PMN Number
    K173472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27-NOV-2019. LOT 02291S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2020-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION: IN SPINAL LUMBAR FUSION SURGERY AIDED BY PATIENT SPECIFIC GUIDES, ONE OF THE SCREWS IS FOUND TO BE IN A POSITION JUDGED INCORRECT BY THE SURGEON. NO DEVICE-RELATED PROBLEM IS EXPECTED TO HAVE CAUSED THIS SITUATION. PATIENT MATCH PLANNING REVIEW: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. OTHER DEVICES INVOLVED IN THE EVENT. PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1921244 (K141988). BATCH REVIEW PERFORMED ON 27-NOV-2019. LOT 1921244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2019. EXPIRATION DATE: 15.07.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1921988 (K141988). BATCH REVIEW PERFORMED ON 27-NOV-2019. LOT 1921988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2019. EXPIRATION DATE: 18.08.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO BACK PAIN. THE TRAJECTORY OF THE PEDICLE SCREW IN L5 RIGHT WAS NOT CORRECT AND THE TIP PROTRUDED OUT OF THE PEDICLE, IT WAS REPOSITIONED THE SAME SCREW. CASE CODE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241062 MYSPINE MC DRILL BASED GUIDE L05 DRILL GUIDE PQC MEDACTA INTERNATIONAL SA 02291S 07630040717557

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention